The $37 Billion Supplement Industry Is Barely Regulated And It’s Allowing Dangerous Products To Slip Through The Cracks

Some supplements (a category that includes vitamins and herbs) can be dangerous and have been linked with ER visits and death

The FDA is currently recalling supplements found to be contaminated with banned drugs and bacteria

New supplement companies like Gwyneth Paltrow’s Goop continue to advertise their products as healthy despite potential side effects, and some say they target vulnerable consumers

When Pouya Jamshidi, a resident at Weill Cornell Medical College, delivered his first baby, the doctor on call told him to take the newborn away from its mother.

The baby, a healthy girl with mocha-pink skin and a powerful set of lungs, was being quarantined.

In the middle of the pregnancy, her mother had come down with tuberculosis. She’d contracted the contagious lung infection in her teens, and the illness came back despite preventative antibiotics and regular screenings. The cause: a popular herbal supplement called St. John’s wort.

“The trouble is most people don’t consider it a medication because you don’t need a prescription for it, and so she didn’t tell us,” Jamshidi told Business Insider.

St. John’s wort is one of the most popular herbal supplements sold in the United States. But in 2000, the National Institutes of Health published a study showing that St. John’s wort could severely curb the effectiveness of several important pharmaceutical drugs — including antibiotics, birth control, and antiretrovirals for infections like HIV — by speeding up their breakdown in the body.

“It basically overmetabolized the antibiotics so they weren’t in her system in the correct dose,” Jamshidi said.

The findings on St. John’s wort prompted the US Food and Drug Administration to warn doctors about the herbal remedy. But that did little to stem public sale or consumption of it. Over the past two decades, US poison-control centers have gotten about 275,000 reports — roughly one every 24 minutes — of people who reacted badly to supplements; a third of them were about herbal remedies like St. John’s wort.

Overdosing on a ‘natural’ supplement

The FDA defines supplements as products “intended to add further nutritional value to (supplement) the diet.” They aren’t regulated as drugs — only when a supplement is shown to cause significant harm is it called out as unsafe.

Half of all adult participants in a survey in the mid-2000s said they took at least one supplement every day — almost the same percentage of Americans who took them two decades ago. Yet research has consistently found the pills and powders to be ineffective and sometimes dangerous.

“Consumers should expect nothing from [supplements] because we don’t have any clear evidence that they’re beneficial, and they should be leery that they could be putting themselves at risk,” S. Bryn Austin, a professor of behavioral sciences at the Harvard T.H. Chan School of Public Health, told Business Insider. “Whether it’s on the bottle or not, there can be ingredients in there that can do harm.”

Despite many such warnings, the supplement industry’s market is as much as $37 billion a year, according to one estimate. Ads for supplements can be found on internet pop-up windows, on social media, in magazine pages, and on TV. They’re sold in corner health stores, pharmacies, and big grocery conglomerates.

But supplements do not come with explicit instructions on how much to take — only a suggested dose — or potential drug interactions. Jamshidi’s patient had no idea she was putting her life or that of her baby at risk.

But she was not alone. Using data from 2004 to 2013, the authors of a 2016 study published in the New England Journal of Medicine estimated that 23,005 emergency-room visits a year were linked to supplements. Between 2000 and 2012, the annual rate of negative reactions to supplements — or “exposures” as they are known in scientific parlance — rose from 3.5 to 9.3 cases per 100,000 people, a 166% increase.

Over that period, 34 people died as a result of using supplements, according to a 2017 study published in the Journal of Medical Toxicology. Six of the deaths resulted from ephedra, the once popular weight-loss supplement banned by the FDA in 2004, and three people died from homeopathic remedies. One person died after using yohimbe, an herbal supplement used for weight loss and erectile dysfunction. (Certain formulations of it can be prescribed to treat erectile dysfunction.)

‘You don’t know what you’re dealing with’

Jamshidi said he knew many people who took a daily multivitamin and tried herbal formulations now and again when they were feeling tired or unwell and always withheld judgement. But he remembers the moment he became wary of supplements: when the pregnant woman his team was monitoring began coughing up phlegm.

“She had been an incredibly cooperative patient, super engaged and always showing up on time for her visits, taking all of our instructions carefully — just a really good patient,” Jamshidi said.

Business Insider / Skye Gould

When Jamshidi and his team realized their patient’s tuberculosis was back, they asked if she’d started any new medications. She said no, but the next day she arrived at the clinic with a small bottle of St. John’s wort.

She said she had been taking the herbal remedy for the feelings of depression she experienced after her last pregnancy. Although some small studies initially suggested St. John’s wort could have benefits for people with depressive symptoms, the NIH researchers failed to find enough evidence to support that.

Jamshidi’s patient had to be isolated to ensure the infection didn’t spread. She spent the last three months of her pregnancy alone.

“It was miserable — she was isolated for all that time, and then she couldn’t even hold the baby,” Jamshidi said.

In his opinion, one of the reasons many people end up in emergency rooms after taking supplements is that the quantities of active ingredients in them can vary dramatically. A 2013 study published in the journal BMC Medicine found that doses of ingredients in supplements could even vary from pill to pill — which poses a significant hurdle for doctors trying to treat a negative reaction.

“There are other medications that can have side effects, but patients come in and tell you the dose, and you can reverse it,” Jamshidi said. “But with supplements, you don’t know what you’re dealing with.”

‘Vitamines’ to prevent disease

By isolating the first “vitamine” in 1912, the Polish chemist Casimir Funk unwittingly unleashed a frenzy among chemists to create or synthesize vitamins in the lab.

Between 1929 and 1943, 10 Nobel Prizes were awarded for work in vitamin research. By the mid-1950s, scientists had synthesized 12 of the 13 essential vitamins. These were added to foods like bread, cereal, and milk, which were sold as “fortified.” Foods that lost nutrients during processing got these vitamins added back in and were labeled “enriched.”

When supplements were introduced in the 1930s and 1940s, they were presented as a way to address nutrient deficiencies that caused illnesses like rickets and scurvy. They were also seen as a way to avoid expensive and difficult-to-access medical treatment.

In recent years, however, a new generation of supplements has emerged targeting primarily middle-class and affluent women. These formulas ooze with the lifestyle trends of 2017: minimalism (“Everything you need and nothing you don’t!”), bright colors, “clean eating,” and personalization.

The actress Gwyneth Paltrow’s new lineup of $90 monthly vitamin packs — released through her controversial wellness company, Goop — have appealing names like “Why Am I So Effing Tired” and “High School Genes.” They claim to deliver health benefits like energy boosts and metabolism jump-starts.

“What is different about what Goop offers is that the combinations, the protocols put together, were done by doctors in Goop’s team,” Alejandro Junger, a cardiologist who helped design several of Goop’s multivitamin packs, told Business Insider.

But a look at the ingredients in “Why Am I So Effing Tired,” which Junger helped design, suggests the formula is not based on rigorous science. The vitamin packets include 12.5 milligrams of vitamin B6 — about 960% of the recommended daily allowance (although on Goop’s label it is listed as 625%) — and ingredients like rosemary extract and Chinese yam, whose effects have never been studied in humans and for which no standard daily allowance exists.

Goop

According to the Mayo Clinic, vitamin B6 is “likely safe” in the recommended daily intake amount: 1.3 milligrams for people ages 19-50. But taking too much of the supplement has been linked with abnormal heart rhythms, decreased muscle tone, and worsened asthma. High doses of B6 can also cause drops in blood pressure, the Mayo Clinic notes, and can interact with drugs like Advil, Motrin, and those prescribed for anxiety and Alzheimer’s.

“People using any medications should check the package insert and speak with a qualified healthcare professional, including a pharmacist, about possible interactions,” the Mayo Clinic’s website says.

Junger declined to comment on specific ingredients in the formula but said that many of them were added to “address the most common nutrient-mineral deficiencies of today: B, C, D, and E vitamins, iodine, magnesium, molybdenum, among others.”

Other shiny new pills and powders that have materialized in recent months include one called Ritual, which arrives at your doorstep in a white-and-yellow box emblazoned with the words “The future of vitamins is clear.”

A month’s supply of the glasslike capsules — filled with tiny white beads suspended in oil — costs $30. But the pills don’t differ much more than your standard, cheaper multivitamin — they have similar amounts of magnesium, vitamin K, folate, vitamin B12, iron, boron, vitamin E, and vitamin D.

VitaMe, another new supplement manufacturer, ships personalized daily packets with names like “Good Hair Day” and “Bridal Boost” in a box resembling a tea-bag dispenser each month for $40.

Its website says: “Our mission is peak nutrition. Delivered.” But its ingredients don’t differ drastically from those in conventional vitamins either.

One of Ritual’s supplements. Ritual

When vitamins can’t save us from ourselves

No matter how colorful their packaging or messaging, all these supplements fall prey to the same problem: We simply do not need them to be healthy.

“We use vitamins as insurance policies against whatever else we might (or might not) be eating, as if by atoning for our other nutritional sins, vitamins can save us from ourselves,” Catherine Price, a science reporter, writes in the book “Vitamania.”

A large recent review published in the Annals of Internal Medicine looked at 27 trials of vitamins involving more than 400,000 people. The researchers concluded that people who took vitamins did not live longer or have fewer cases of heart disease or cancer than people who did not take them.

Another long-term study published in the Journal of the American Medical Association in May divided nearly 6,000 men into groups and gave them either a placebo or one of four supplements touted for their brain-protecting abilities. The results showed no decreased prevalence of dementia among any of the supplement-taking groups.

Study after study has also found that many popular supplements can cause harm. A large, long-term study of male smokers found that those who regularly took vitamin A were more likely to get lung cancer than those who didn’t. And a 2007 review of trials of several types of antioxidant supplements put it this way: “Treatment with beta carotene, vitamin A, and vitamin E may increase mortality.”

Risks aside, research has suggested that our bodies are better equipped to process the vitamins and minerals in whole foods than those in pills. When we bite into a juicy peach or a crunchy Brussels sprout, we’re ingesting dozens of nutrients, including phytochemicals like isothiocyanates, as well as carotenoids.

Austin said that’s why “nutritionists recommend people get their nutrition from whole foods, not things that have been packaged and put into a box.”

After spending the last few months of her pregnancy and the first few weeks of her new baby’s life in isolation, Jamshidi’s patient was able to go home and be with her family. Jamshidi said the experience changed the way he thought about supplements for good.

“I feel very negatively about them, and I didn’t feel this way going into it,” he said.

Ask Steven Tave, the director of the office of dietary supplement programs at the FDA, why the agency isn’t stopping more similar situations, and he’ll give a simple answer: “We’re doing the best we can.”

In 1994, Congress passed a controversial law called the Dietary Supplement Health and Education Act. Tave said that before DSHEA passed, the FDA was starting to regulate supplements more stringently, the way it does pharmaceutical drugs, but getting “pushback from the industry.” The law forced the agency to be more lenient.

Before a new drug can be sold, the company making it has to apply for FDA approval, and the agency has to conclude that the drug is safe and does what it claims to do.

“So if the drug says, you know, ‘used to treat cancer,’ then the agency’s reviewers are going to look at it and make a determination that there’s evidence that it does treat cancer,” Tave said.

New supplements don’t face any burden of proof. The agency can review products that add new dietary ingredients when it gets a notification, Tave said, but it doesn’t “have the authority to stop anything from going to market.”

When DSHEA was passed, Tave said, the bill still made sense. In 1994, about 600 supplement companies were producing about 4,000 products for a total revenue of about $4 billion. But that market has since ballooned — today, close to 6,000 companies pump out about 75,000 products.

“We’re regulating that with 26 people and a budget of $5 million,” Tave said.

Removing a supplement from store shelves comes down to documented emergency-room visits and calls to poison-control centers. Only when a supplement is reported to be unsafe as a result of one of these “adverse events,” as the FDA calls them, is the agency compelled to act.

“Most of the time, we don’t know a product is on the market until we see something bad about it from an adverse-event report. It’s a very different regime from when we know everything is out there and we know what’s in it,” Tave said, adding: “We don’t want to be reactive. We want to be proactive. But we can’t be.

‘Consumers have no way to know’

Most unsafe supplements have been found to contain ingredients that aren’t listed on their labels — usually, these are pharmaceutical drugs, some of which have been banned by the FDA.

A study of product recalls published in 2013 in the Journal of the American Medical Association found that of the 274 supplements recalled by the FDA between 2009 and 2012, all contained banned drugs. A 2014 report found that more than two-thirds of the supplements purchased six months after being recalled still contained banned drugs.

“The products we see today have gone way beyond that sort of core group that they were in 1994,” Tave said. “Now they’re promoted for all sorts of things — some are long term, some are short term, some are chemicals no one’s ever seen before. It’s a much different universe than it was at the time.”

Austin says three categories of supplements are the “most lawless of the industry”: physical enhancement, weight loss, and sexual performance.

“Some of these companies won’t identify ingredients that they purposefully put in the products,” she said. “Some weight-loss drugs, for example, that have been pulled from the market — we can still find these in the bottle even though they don’t put it on the label.”

Tave’s 26-person team, the only government employees looking into these issues, didn’t even have a dedicated office until about a year and a half ago.

“We’re pretty sure were not aware of everything that’s out there, but we do what we can,” he said. “All we can do is enforce the law.”

Dangerous supplements continue to seep through the cracks, however.

In 2016, the world’s largest supplement maker, GNC Holdings Inc., agreed to pay $2.25 million to avoid federal prosecution over allegations that it sold a performance-enhancing supplement that claimed to increase speed, strength, and endurance with an active ingredient called dimethylamylamine, or DMAA. Two soldiers who used the supplement died in 2011, which prompted the Defense Department to remove all products containing DMAA from stores on military bases.

A recent indictment against USPlabs, the Texas-based company that made the supplement, accused it of falsely claiming the product was made of natural plant extracts when it really contained synthetic stimulants made in China.

The problems are ongoing. Earlier this year, the FDA recalled several supplements after they were found to contain unapproved new drugs, and two more were recalled after they were found to contain unlisted anabolic steroids. On August 11, just days before this article was published, the FDA recalled another batch of supplements — this time pills manufactured by a company called PharmaTech — because of possible contamination with bacteria that can cause serious respiratory infection.

“Consumers have no way to know that what’s in the label is what’s actually in the bottle or box,” Austin said. “There are many dubious companies out there that are willing to take a risk with consumers health and their lives.”

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